Effects of Armeo Power Robot Therapy on Upper Limb Recovery in Hemiplegic Stroke Patients (BV108/RAPPHCN)

Hanoi Medical University

Status: Completed

Conditions: Rehabilitation of Upper Limb Motor Function in Hemiplegia Due to Supratentorial Cerebral Infarction Using Armeo Power Robot

Treatments: Device: Armeo Power robot restores upper limb motor function.; Behavioral: A Home Exercise Program; Behavioral: Occupational therapy activities

Study type: Interventional

Funder types: Other

Identifiers

NCT06708065

1139/GCN-HMUIRB

Details and patient eligibility

About

This study investigates the effectiveness of combining Armeo Power robotic therapy with conventional rehabilitation techniques to improve upper limb motor function in patients with hemiplegia caused by supratentorial cerebral infarction (a type of stroke). The study aims to evaluate how robotic-assisted therapy can enhance recovery by measuring motor function improvements over three weeks of treatment. Participants will undergo standard physical and occupational therapy alongside Armeo Power training, with results compared to those receiving only standard rehabilitation. The findings aim to provide valuable insights into advanced therapeutic options for stroke rehabilitation.

Enrollment: 84 patients

Sex: All

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

• Spasticity of the affected arm with a Modified Ashworth Scale score ≤ 2.
• Patients must have good cognition and awareness (MoCA score ≥ 26).
• Patients must have good vision and visual perception.
• Patients must have stable sitting posture and good sitting balance.
• Body weight and affected arm size must be compatible with the robotic arm device.
• Patients must agree to participate in the study and adhere to the training protocol.

Exclusion Criteria

• Spasticity with a Modified Ashworth Scale score ≥ 3.
• Severe sensory impairment in the affected limb.
• Patients with arthritis or joint stiffness.
• Hemiplegia caused by conditions other than stroke.
• Pre-existing motor disabilities in the affected limb before the stroke.
• Skin lesions on the limb requiring rehabilitation.
• Uncontrolled epilepsy.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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84 participants in 2 patient groups

ARMEO group

Experimental group

Description:

The intervention group consisted of 42 patients who received standard physical therapy and occupational therapy for 90 minutes per day, five days per week. Additionally, these patients underwent training with the ArmeoPower robotic system for 45 minutes per day, five days per week.

Treatment:

Behavioral: Occupational therapy activities

Behavioral: A Home Exercise Program

Device: Armeo Power robot restores upper limb motor function.

Control group

Active Comparator group

Description:

The control group comprised 42 patients who participated in standard physical therapy and occupational therapy for 90 minutes per day, five days per week. In addition, these patients were instructed to engage in home-based practice for 45 minutes per day, five days per week, guided by direct instructions and exercise leaflets provided by the therapists.

Treatment:

Behavioral: Occupational therapy activities

Behavioral: A Home Exercise Program